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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

EMA Committee Finds No Link Between HPV Vaccines and Rare Conditions

After reviewing the safety profile of human papillomavirus (HPV) vaccines, a European Medicines Agency's (EMA) committee found no evidence the vaccines cause two rare conditions in young women, concluding that "there is no reason to change the way the vaccines are used."

PRAC Review

There are currently three centrally-authorized HPV vaccines in the EU – Gardasil/Silgard, Gardasil 9 and Cervarix – to protect against cervical cancer and other HPV related conditions.

Upon initiating its review, EMA stated its goal was to "clarify aspects of [the vaccines'] safety profile," and said the review did not question whether "the benefits of HPV vaccines outweigh their risks."

To conduct the review, PRAC consulted with "leading experts in the field" and "thoroughly reviewed the published research, data from clinical trials and reports of suspected side effects from patients and healthcare professionals, as well as data supplied by Member States."

PRAC estimates that approximately 150 per million girls and young women develop CRPS and POTS each year, but "found no evidence that the overall rates of [CRPS and POTS] in vaccinated girls were different from expected rates," even when factoring for underreporting.

The committee also acknowledged that more than 80 million girls and women worldwide have received HPV vaccines and the vaccine "is expected to prevent many cases of cervical cancer … which is responsible for tens of thousands of deaths in Europe each year."

PRAC is recommending there be no changes to how the vaccine is used, and finds no reason to change the product information.